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How to balance concerns over addiction and abuse of prescription painkillers with patient needs for pain treatment remains the key question after an FDA panel voted in favor of greater restrictions, Ed Silverman writes.

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Parental abuse of opioids such as heroin and prescription painkillers is largely responsible for a national rise in home removals of children. A Vermont survey found opioid use was involved in 80% of cases where a child younger than 3 was taken into custody. Agencies are struggling to meet the burden and addiction treatment has had limited success.

Reps. Vern Buchanan, R-Fla., and Edward Markey, D-Mass., have urged the FDA to reclassify painkillers containing hydrocodone from Schedule III to Schedule II. The move would limit the quantity of pills that could be dispensed at one time and would mandate a written prescription for the frequently abused drugs.

Amgen and Genentech are among the drugmakers pushing state legislatures to restrict substitution of biosimilar drugs for expensive branded biologic therapies. Bills under consideration would require patient consent and doctor notification before a biosimilar may be substituted and would mandate that only drugs deemed "interchangeable" by the FDA could be substituted.

Nonprofit health insurance plans founded under the Affordable Care Act's Consumer Oriented and Operated Plan program are gearing up to compete with national insurers once insurance marketplaces commence operations. The founder of New Mexico Health Connections is targeting the state's lower-income population through Federally Qualified Health Centers and hopes to differentiate his plan with services that bigger plans often do not offer. Evergreen Health Cooperative, started by Howard County, Md., officials, plans to offer Baltimore-area residents a medical home model and a more traditional plan statewide.

A two-day public hearing is being planned by the FDA in early February to find a balance between patient needs for prescription painkillers and ongoing concerns over addiction and abuse. In addition, the agency expects to introduce a guideline on developing tamper-resistant opioid pain drugs. An FDA panel is also set to discuss the benefits and risks of using hydrocodone combinations as cough suppressants or pain relievers.